MedPath

Ibuprofen

DG-Ibuprofen Capsules, 200mg

Approved
Approval ID

03138a6f-653a-f359-e063-6394a90ac5d6

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 27, 2025

Manufacturers
FDA

DOLGENCORP INC

DUNS: 068331990

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Ibuprofen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55910-518
Application NumberANDA078682
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ibuprofen
Product Specifications
Route of AdministrationORAL
Effective DateMay 27, 2025
FDA Product Classification

INGREDIENTS (8)

POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SORBITANInactive
Code: 6O92ICV9RU
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYETHYLENE GLYCOL 600Inactive
Code: NL4J9F21N9
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
IBUPROFENActive
Quantity: 200 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/27/2025

20's carton label -MADE IN INDIA

DG health

Compare to the active
** ingredient of Advil ®**
** LIQUI-GELS ®†**

Ibuprofen

Capsules, 200 mg
** Pain Reliever/Fever Reducer**
** (NSAID)**

200 mg

20 Softgels**

(Liquid Filled Capsules)
** Actual Size

carton

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 10/26/2023

Uses

  • temporarily relieves minor aches and pains due to:
  • headache
  • toothache
  • backache
  • menstrual cramps
  • the common cold
  • muscular aches
  • minor pain of arthritis
  • temporarily reduces fever

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 10/26/2023

Active ingredient (in each capsule)

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*

(present as the free acid and potassium salt)

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 10/26/2023

Purpose

Pain reliever/Fever reducer

*nonsteroidal anti-inflammatory drug

WARNINGS SECTION

LOINC: 34071-1Updated: 10/26/2023

Warnings

**Allergy alert:**Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.
Symptoms may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
  • skin reddening
  • rash
  • blisters. If an allergic reaction occurs, stop use and seek medical help right away.

**Stomach bleeding warning:**This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed
    **Heart attack and stroke warning:**NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do not use

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 10/26/2023

Ask a doctor before use if

  • stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
  • you are taking a diuretic

OTC - ASK DOCTOR/PHARMACIST SECTION

LOINC: 50568-5Updated: 10/26/2023

Ask a doctor or pharmacist before use if you are

  • under a doctor's care for any serious condition
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • taking any other drug

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 10/26/2023

When using this product

  • take with food or milk if stomach upset occurs

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 10/26/2023

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke:
  • chest pain
  • trouble breathing
  • weakness in one part or side of body
  • slurred speech
  • leg swelling
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • any new symptoms appear

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 10/26/2023

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 10/26/2023

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 10/26/2023

Directions

*do not take more than directed *the smallest effective dose should be used

  • adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 capsule, 2 capsules may be used
  • do not exceed 6 capsules in 24 hours, unless directed by a doctor
  • children under 12 years: ask a doctor

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 10/26/2023

Other information

  • each capsule contains: *potassium 20 mg
  • read all warnings and directions before use. Keep carton.
  • store at 20° to 25°C (68° to 77°F)
  • avoid excessive heat above 40°C (104°F). Protect from light.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/27/2025

Inactive ingredients

FD&C Blue #1, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan and sorbitol

For India Manufacturing Site:

FD&C Blue #1, gelatin, polyethylene glycol,potassium hydroxide, purified water, sorbitan and sorbitol

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 10/26/2023

Questions or comments?

call toll-free1-888-309-9030

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/27/2025

DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

†This product is not manufactured or distributed by the owners of Advil ®LIQUI-GELS ®.

DISTRIBUTED BY OLD EAST MAIN CO., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072
100% SATISFACTION GUARANTEED!(888) 309-9030

L0000741

R0823

For India Manufacturing Site:

MADE IN INDIA

Code: TN/DRUGS/TN/25/00074

L0000965

R0225

P3306/00/25

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